FDA recall D-1627-2020

Product

pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.

Reason for recall

Marketed without an Approved NDA/ANDA.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-09-02

Report date

2020-10-07

Termination date

2022-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1627-2020